Librax® — Chlordiazepoxide 5 mg + Clidinium Bromide 2.5 mg — Sugar-Coated Tablets — Oral Use
1. Disclaimer
This monograph is intended for healthcare professionals and for medical and pharmaceutical information purposes. It does not replace the current locally approved prescribing information, individual clinical assessment, or the judgment of a qualified healthcare professional. Product formulation, approved indications, dosing instructions, legal classification, manufacturer information, and availability may vary between countries and may change over time.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
For use in Egypt, the current Egyptian package insert and requirements of the Egyptian Drug Authority and other competent authorities should take precedence whenever they differ from information published for Librax in other markets.
2. Summary
Librax® is a fixed-dose combination of chlordiazepoxide, a benzodiazepine with anxiolytic and CNS-depressant properties, and clidinium bromide, a synthetic antimuscarinic agent with gastrointestinal antispasmodic and antisecretory activity.
The combination is intended mainly for gastrointestinal disorders in which anxiety/tension and gastrointestinal spasm coexist. Contemporary regulatory labeling supports use in conditions such as anxiety associated with functional spastic gastrointestinal symptoms and, depending on the jurisdiction, as adjunctive treatment of peptic ulcer, irritable bowel syndrome and acute enterocolitis.
Because the product contains a benzodiazepine, treatment requires particular attention to sedation, impaired psychomotor performance, abuse and misuse, physical dependence, withdrawal reactions, and the potentially fatal interaction with opioids and other CNS depressants.
3. Brand Name
Librax®
The Egyptian product is currently listed by Egyptian pharmacy sources as Librax 30 sugar-coated tablets, containing chlordiazepoxide 5 mg and clidinium bromide 2.5 mg per tablet and manufactured/marketed under EIPICO branding.
4. Category
Pharmacotherapeutic category:
- Benzodiazepine anxiolytic + antimuscarinic gastrointestinal antispasmodic.
- ATC classifications associated with the components include N05BA02 for chlordiazepoxide and A03CA02 for clidinium in combination with psycholeptics.
This is a prescription medicine. Its legal or controlled-drug status varies by jurisdiction and must be checked under applicable national regulations. For example, although chlordiazepoxide itself is a Schedule IV controlled substance in the United States, the branded Librax combination listed by DailyMed is exempted from Schedule IV and is not controlled under the U.S. Controlled Substances Act.
5. Active Ingredient
Each tablet contains:
Chlordiazepoxide — 5 mg
Clidinium bromide — 2.5 mg
Chlordiazepoxide is a benzodiazepine.
Clidinium bromide is a synthetic quaternary ammonium antimuscarinic agent.
The same 5 mg/2.5 mg combination is confirmed in current regulatory Librax product information.
6. Pharmaceutical Form & Strength
Pharmaceutical form: Sugar-coated/coated oral tablet.
Strength per tablet:
- Chlordiazepoxide 5 mg.
- Clidinium bromide 2.5 mg.
Egyptian pack currently encountered: Box of 30 tablets.
International Librax presentations also include capsules containing the same strengths; however, formulation-specific instructions should always follow the product supplied in the relevant country. The current French coated-tablet presentation also contains 30 tablets, whereas the current U.S. Librax product is supplied as capsules.
7. Manufacturer & Marketing Authorization Holder
Egyptian-market manufacturer:
Egyptian International Pharmaceutical Industries Company (EIPICO), Egypt.
Current Egyptian pharmacy listings identify EIPICO as the manufacturer/company associated with Librax 30 tablets. EIPICO is an Egyptian pharmaceutical manufacturer headquartered in Tenth of Ramadan City.
A sufficiently current publicly accessible Egyptian regulatory record establishing the exact present marketing authorization holder for this specific presentation was not identified. The current Egyptian outer carton/package insert or Egyptian Drug Authority record should therefore be checked before stating a separate marketing authorization holder.
8. Mechanism of Action
Chlordiazepoxide
Chlordiazepoxide acts at benzodiazepine-sensitive sites associated with the GABA-A receptor complex, enhancing GABA-mediated inhibitory neurotransmission. Its pharmacological properties include anxiolytic, sedative, hypnotic, anticonvulsant, muscle-relaxant and amnestic effects.
Clidinium bromide
Clidinium is a synthetic anticholinergic/antimuscarinic agent with a spasmolytic effect on smooth muscle and an inhibitory effect on secretions.
The combination therefore addresses both the central anxiety/tension component and peripheral gastrointestinal spasm.
9. Spectrum of Activity
Not applicable in the antimicrobial sense.
Librax is not an antibiotic, antifungal, antiviral or antiparasitic medicine and therefore has no antimicrobial spectrum.
Its pharmacological activity consists of:
- CNS anxiolytic and sedative activity from chlordiazepoxide.
- Peripheral antimuscarinic, antispasmodic and antisecretory gastrointestinal activity from clidinium.
10. Pharmacokinetics
Chlordiazepoxide
Chlordiazepoxide is well absorbed after oral administration. Current French coated-tablet regulatory information reports peak plasma concentrations approximately 1–2 hours after administration and oral bioavailability close to 100%. Reported elimination half-life values vary between pharmacokinetic descriptions; the current French RCP reports a range of approximately 6–30 hours and also cites a half-life of approximately 20–24 hours.
It undergoes hepatic metabolism successively to desmethylchlordiazepoxide and demoxepam, which are weakly active, followed by formation of the active metabolite oxazepam in only very small amounts. According to the current French RCP, less than 1% of ingested chlordiazepoxide ultimately results in oxazepam formation. Urinary elimination occurs mainly in the form of demoxepam and oxazepam. Active metabolites reach steady-state more slowly than the parent compound and may contribute to accumulation during repeated administration, particularly in susceptible patients.
Clidinium bromide
Systemic pharmacokinetic information is substantially more limited. Current coated-tablet product information reports metabolism to a hydroxy metabolite, with clidinium and its metabolite recovered in excreta. As a quaternary ammonium anticholinergic, penetration into the central nervous system is limited compared with tertiary antimuscarinic compounds.
11. Indications
Contemporary product information supports Librax primarily for gastrointestinal conditions associated with anxiety/tension and spasm.
Depending on the locally approved indication, uses include:
- Symptomatic treatment of severe or disabling anxiety associated with functional gastrointestinal disorders having a spastic component.
- Control of emotional and somatic factors associated with gastrointestinal disorders.
- Adjunctive treatment of peptic ulcer disease.
- Irritable bowel syndrome, including historically described irritable/spastic colon.
- Acute enterocolitis in jurisdictions where this indication remains approved.
The medicine does not replace specific treatment of an underlying gastrointestinal disease.
Use for other disorders should only be undertaken when supported by the current locally approved product information and the prescriber's clinical judgment.
12. Administration
Route: Oral.
Dosage should be individualized and the lowest effective dose should be used.
For the currently authorized French coated-tablet formulation, the usual adult dosage is 1 tablet 2–4 times daily. Some publicly accessible Egyptian pharmacy listings describe 1 tablet three times daily before meals; however, this should not be regarded as confirmed official Egyptian prescribing information. The dose for the Egyptian product should follow the treating physician and the current locally approved Egyptian package insert.
The tablets should be swallowed with a small amount of water. Current French prescribing information states that administration may take place with meals, at bedtime, or at the time of pain.
For older adults below 75 years of age, patients with renal impairment, and patients with mild-to-moderate hepatic impairment, the current French labeling recommends dose reduction, for example by approximately one-half. Patients aged 75 years or older are contraindicated under that specific French labeling.
Treatment should generally be as short as clinically possible. Current French prescribing information states that the total duration for most patients should not exceed 8–12 weeks, including the period of gradual dose reduction, unless continued treatment is specifically reassessed and justified.
Do not abruptly discontinue Librax after continued use. A patient-specific gradual dose reduction may be required to prevent potentially serious or life-threatening benzodiazepine withdrawal reactions.
13. Method of Preparation
No preparation or reconstitution is required.
Librax tablets are supplied ready for oral administration. Swallow the prescribed tablet with a small amount of water.
Do not alter the dose or divide/crush the dosage form unless specifically permitted by the current product information or instructed by a healthcare professional.
14. Contraindications
Librax should not be used in patients with hypersensitivity to chlordiazepoxide, clidinium bromide or relevant formulation ingredients.
The current French prescribing information for Librax coated tablets lists the following contraindications:
- Patients aged over 75 years.
- Patients aged over 65 years with multiple comorbidities (polypathology).
- Risk of angle-closure glaucoma.
- Risk of urinary retention related to urethro-prostatic disorders.
- Breastfeeding.
- Severe respiratory insufficiency.
- Sleep-apnea syndrome.
- Severe acute or chronic hepatic impairment.
- Myasthenia gravis.
Contraindication lists are jurisdiction-specific. Other regulatory product information may include additional contraindications. For example, Canadian labeling has included cardiovascular instability, history of drug abuse or dependence, hiatal hernia with reflux esophagitis, intestinal atony in elderly or debilitated patients, intestinal obstruction, prostatic hypertrophy/urinary retention, and ulcerative colitis. Local prescribing information must therefore be checked before use.
15. Warnings & Precautions
Opioids and respiratory depression
Concomitant benzodiazepine and opioid use can cause profound sedation, respiratory depression, coma and death. Concomitant prescribing should be reserved for circumstances in which adequate alternatives are unavailable, using the lowest effective doses and shortest practicable duration with close monitoring.
Abuse, misuse and addiction
Chlordiazepoxide exposes patients to risks of benzodiazepine abuse, misuse and addiction, including overdose and death, particularly when combined with alcohol, opioids or other CNS depressants.
Physical dependence and withdrawal
Continued treatment can cause clinically significant physical dependence even when a benzodiazepine is taken therapeutically. Abrupt discontinuation or rapid dose reduction may produce severe withdrawal reactions, including seizures and potentially life-threatening neuropsychiatric effects. Gradual tapering is required when clinically indicated.
CNS and psychomotor impairment
Sedation, dizziness, impaired coordination, amnesia, impaired concentration and reduced psychomotor performance may occur. Patients should not drive, operate machinery or undertake hazardous activities until their individual response is known.
Alcohol
Alcohol should be avoided because it potentiates sedation and psychomotor impairment and may increase the risk of dangerous CNS and respiratory depression.
Paradoxical psychiatric reactions
Agitation, irritability, aggression, disinhibition, hallucinations, nightmares, abnormal behavior and other paradoxical reactions may occasionally occur, especially in susceptible or elderly patients.
Depression and suicide risk
Benzodiazepines should not be relied upon as sole treatment of major depressive illness. Patients with depression or suicidal risk require appropriate assessment and monitoring.
Anticholinergic precautions
Clidinium can worsen urinary retention, constipation, glaucoma and gastrointestinal atony. Particular caution is needed in conditions such as prostatic hypertrophy, renal impairment, mild-to-moderate hepatic impairment, coronary insufficiency, cardiac arrhythmias, hyperthyroidism, chronic bronchitis, paralytic ileus, intestinal atony in older patients and toxic megacolon.
16. Drug Interactions
Opioids: Major interaction. Additive CNS and respiratory depression may cause profound sedation, coma or death.
Alcohol: Avoid. It markedly enhances CNS depression and impairment.
Other CNS depressants: Sedating antihistamines, hypnotics, barbiturates, other benzodiazepines/anxiolytics, antipsychotics, sedating antidepressants, centrally acting analgesics, centrally acting antihypertensives, baclofen and similar medicines may enhance sedation and CNS depression.
Sodium oxybate: Concomitant use is not recommended because of additive sedative/CNS-depressant effects.
Other anticholinergic medicines: Additive effects may increase dry mouth, blurred vision, constipation, urinary retention and risk of an acute glaucoma attack.
CYP inhibitors: Chlordiazepoxide is metabolized predominantly through pathways involving CYP3A4 and CYP2C19; inhibitors of these enzymes may increase plasma chlordiazepoxide concentrations and excessive sedation.
Cimetidine: At doses ≥800 mg/day, current French labeling identifies an increased risk of drowsiness, with particular caution regarding driving or operating machinery.
Anticholinesterases: Clidinium may reduce their effectiveness through pharmacodynamic antagonism at acetylcholine receptors.
Morphine derivatives/opioids: In addition to CNS and respiratory depression from chlordiazepoxide, concomitant morphine derivatives with anticholinergic agents such as clidinium may markedly increase the risk of colonic hypomotility and severe constipation.
Oral anticoagulants: Variable effects on coagulation have historically been reported with chlordiazepoxide, although a definite causal relationship has not been established.
Patients should inform the prescriber of all prescription medicines, OTC products and sedating or anticholinergic agents before treatment.
17. Side Effects
Frequently or clinically important reported adverse effects include:
- Sedation and drowsiness.
- Dizziness.
- Reduced alertness.
- Ataxia and impaired balance/coordination.
- Fatigue.
- Confusion, particularly in elderly patients.
- Dry mouth.
- Blurred vision or impaired accommodation.
- Constipation.
- Gastrointestinal disturbances.
- Difficulty initiating urination or urinary retention.
- Tachycardia or palpitations.
- Muscle weakness/hypotonia.
- Changes in libido.
Less common or potentially serious effects include:
- Paradoxical agitation, irritability, aggression, hallucinations or behavioral changes.
- Anterograde amnesia.
- Hypotension.
- Respiratory depression.
- Jaundice, hepatitis or abnormal liver enzymes.
- Allergic skin reactions, urticaria or edema.
- Rare bone-marrow depression including thrombocytopenia, leukopenia, agranulocytosis or pancytopenia.
- Dependence, withdrawal syndrome or rebound anxiety.
- Seizures during severe benzodiazepine withdrawal.
Immediate medical evaluation is required for severe breathing difficulty, marked sedation, loss of consciousness, seizures, severe confusion or serious allergic reactions.
18. Use in Special Populations
Pregnancy
Benzodiazepines cross the placenta. Available observational data have not demonstrated a clear overall association between benzodiazepine exposure and major congenital malformations, although some studies have reported a possible small increase in oral clefts. Use later in pregnancy can produce fetal or neonatal effects including reduced fetal movement, altered fetal heart-rate variability, neonatal hypotonia, feeding difficulties, respiratory depression/apnea, hypothermia and neonatal withdrawal.
Current French Librax labeling advises against use throughout pregnancy as a precaution.
Contraception and Reproductive Precautions
Because the current French RCP identifies a potential genotoxic concern associated with chlordiazepoxide, it recommends that:
- Women of childbearing potential use effective contraception during treatment and for 7 months after discontinuation.
- Men use effective contraception and avoid fathering a child during treatment and for 4 months after discontinuation.
These reproductive precautions originate from the current French regulatory labeling and should not automatically be assumed to represent identical requirements in every jurisdiction.
Breastfeeding
The current French coated-tablet labeling lists breastfeeding as a contraindication, principally because clidinium may reduce milk secretion and is described as passing into breast milk with a potential risk of anticholinergic effects in the infant; chlordiazepoxide is also described as capable of passing into breast milk and its use during breastfeeding is not recommended.
By contrast, current U.S. labeling states that direct data on the presence of either chlordiazepoxide or clidinium in human milk are lacking. It notes reports of sedation, poor feeding and poor weight gain with other benzodiazepines and that clidinium, like other anticholinergic drugs, may suppress lactation. Infants exposed through breast milk should therefore be monitored where use is considered under U.S. labeling.
Pediatric patients
Safety and effectiveness have not been adequately established. Current French labeling states that Librax should not be used in children because clinical studies with the combination are lacking.
Elderly patients
Older adults are particularly susceptible to sedation, confusion, ataxia, balance impairment and falls. Regulatory recommendations differ by jurisdiction. Current French labeling contraindicates use in patients over 75 years, and in polypathological patients over 65 years; for older patients below 75 years in whom treatment is permitted, dosage reduction is recommended.
Renal impairment
Use cautiously. Current French labeling recommends dose reduction in renal impairment, for example to approximately one-half of the usual dose, because accumulation may occur.
Hepatic impairment
Use cautiously in mild-to-moderate hepatic impairment and reduce the dose where appropriate. Severe acute or chronic hepatic impairment is contraindicated under current French labeling because of the risk of encephalopathy and impaired benzodiazepine handling.
Respiratory impairment
Use particular caution in mild-to-moderate respiratory insufficiency because benzodiazepines may worsen respiratory depression. Severe respiratory insufficiency is contraindicated under current French labeling.
19. Storage Conditions
Storage instructions should follow the current Egyptian package because requirements can differ among marketed formulations.
International Librax labeling provides the following useful references:
- U.S. capsules: store at 25°C, with permitted excursions between 15°C and 30°C, in a tight, light-resistant container.
- Current French coated-tablet labeling states no special storage precautions.
These international storage requirements should not be substituted for the storage instructions printed on the currently marketed Egyptian package.
Keep the medicine in its original packaging and out of the sight and reach of children. Do not use after the stated expiry date.
20. Additional Sections
Dependence and Withdrawal
Librax contains chlordiazepoxide and can cause tolerance, physical dependence and addiction. Risk generally increases with higher doses and longer exposure but dependence may occur even at therapeutic doses and in patients without obvious individual risk factors.
Withdrawal symptoms can include insomnia, marked anxiety, headache, muscle pain or tension, irritability, agitation, confusion, paresthesias, hypersensitivity to light, sound or physical contact, depersonalization, derealization, hallucinations and seizures. Protracted withdrawal symptoms lasting weeks or longer have also been reported with benzodiazepines.
Overdose
Overdose may produce combined benzodiazepine and anticholinergic toxicity.
Benzodiazepine manifestations include drowsiness, confusion, lethargy, ataxia, hypotonia, hypotension, respiratory depression and, in severe cases, coma. The risk to life is substantially greater when other CNS depressants, including alcohol or opioids, are involved.
Anticholinergic manifestations may include dry skin and mucous membranes, mydriasis, tachycardia, urinary retention, gastrointestinal hypomotility or ileus, agitation, delirium and hyperthermia.
Suspected overdose requires urgent medical/toxicological assessment, cardiorespiratory monitoring and appropriate supportive management.
Flumazenil must not be regarded as a routine home or nonspecialist antidote. It may be useful in selected benzodiazepine overdoses under specialist supervision, but antagonism of benzodiazepine effects may precipitate neurological complications including seizures, particularly in susceptible patients.
Driving and Operating Machinery
Librax can impair alertness, memory, coordination and reaction time. Sedation, amnesia, impaired concentration and altered muscular function may interfere with driving and operating machinery. Alcohol and other sedating drugs further increase impairment.
21. Frequently Asked Questions (FAQ)
Q1. What is Librax used for?
Librax is mainly used for gastrointestinal symptoms in which anxiety/tension and smooth-muscle spasm are important components. Depending on local authorization, this may include functional spastic gastrointestinal disorders, irritable bowel syndrome and adjunctive treatment of peptic ulcer disease.
Q2. Does Librax directly treat the cause of peptic ulcer disease?
No. It may be used as adjunctive symptomatic therapy where approved, but it does not eradicate Helicobacter pylori and does not replace appropriate acid-suppressive or eradication therapy when such treatment is indicated.
Q3. Can Librax cause dependence?
Yes. Chlordiazepoxide is a benzodiazepine and can cause physical dependence, abuse, misuse and addiction, even when used therapeutically.
Q4. Can Librax be stopped suddenly?
Not after continued regular treatment unless specifically directed by a physician. Abrupt withdrawal or rapid dose reduction may cause serious and potentially life-threatening reactions, including seizures. A gradual individualized taper may be required.
Q5. Can alcohol be consumed while taking Librax?
No. Alcohol can substantially increase sedation, impaired coordination and CNS depression.
Q6. Can Librax be taken with opioid pain medicines?
Only when a clinician determines that the combination is necessary because adequate alternatives are unavailable and treatment can be closely monitored. Combining benzodiazepines with opioids can cause profound sedation, respiratory depression, coma and death.
Q7. Can Librax cause constipation or urinary difficulty?
Yes. These are characteristic anticholinergic effects of clidinium.
Q8. Is Librax suitable for children?
Routine pediatric use is not supported because adequate safety and efficacy have not been established. Current French labeling states that Librax should not be used in children in the absence of clinical studies.
Q9. Can Librax affect driving?
Yes. Drowsiness, dizziness, slowed reaction time, impaired concentration, amnesia and poor coordination may occur.
Q10. How long should treatment continue?
The shortest effective duration should be used. Current French coated-tablet prescribing information states that treatment for most patients should not exceed approximately 8–12 weeks including gradual dose reduction, unless continuation is specifically reassessed and justified. Local Egyptian prescribing instructions take precedence.
22. References
- U.S. National Library of Medicine, DailyMed. Librax® (chlordiazepoxide hydrochloride and clidinium bromide) Capsules for Oral Use. Official U.S. prescribing information and Medication Guide. Label effective January 13, 2023; current SPL version listed by DailyMed.
- U.S. Food and Drug Administration / DailyMed. Librax® prescribing information, NDA 012750. Boxed warning addressing concomitant opioid use, abuse, misuse, addiction, physical dependence and withdrawal reactions.
- French Ministry of Health / Base de Données Publique des Médicaments (ANSM). LIBRAX, comprimé enrobé, chlordiazépoxide 5 mg / bromure de clidinium 2.5 mg. RCP updated September 1, 2025; public medicines database updated September 29, 2026.
- Health Canada. LIBRAX, chlordiazepoxide hydrochloride 5 mg / clidinium bromide 2.5 mg. Product information and Drug Product Database.
- Bausch Health Canada Inc. T/C LIBRAX® Product Monograph. Chlordiazepoxide hydrochloride 5 mg / clidinium bromide 2.5 mg, capsules, oral. Revision December 14, 2021.
- National Center for Biotechnology Information (NCBI). Chlordiazepoxide — pharmacology, mechanism, pharmacokinetics and clinical considerations.
- Greenblatt DJ, Shader RI, MacLeod SM, Sellers EM. Clinical pharmacokinetics of chlordiazepoxide. Clinical Pharmacokinetics. 1978;3(5):381–394.
- Dubey NK, Jain P, Raj A, Tiwari S. A novel LC-MS/MS method for simultaneous estimation of chlordiazepoxide and clidinium in human plasma and its application to pharmacokinetic assessment. Bioanalysis. 2025;17(9):621–628.
- Current Egyptian pharmacy listings for Librax 30 tablets, EIPICO, chlordiazepoxide 5 mg + clidinium bromide 2.5 mg; used only to corroborate the publicly listed Egyptian presentation and not as a substitute for official regulatory labeling.
- EIPICO — Egyptian International Pharmaceutical Industries Company. Official corporate information, Tenth of Ramadan City, Egypt.